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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032595
Receipt No. R000037167
Official scientific title of the study The Use of Yoga for Lumbar Spine Post-Surgical Pain Management
Date of disclosure of the study information 2018/10/18
Last modified on 2018/05/15

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Basic information
Official scientific title of the study The Use of Yoga for Lumbar Spine Post-Surgical Pain Management
Title of the study (Brief title) Yoga following lumbar spine surgery
Region
North America

Condition
Condition Post lumbar spine surgery
Classification by specialty
Surgery in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to is to test the feasibility of a tailored yoga program offered for acute pain management during and immediately after an inpatient hospital stay in a small two armed stratified randomized controlled cross over trial. Acute pain during hospital stay is a major challenge to manage following surgical procedures.
Basic objectives2 Others
Basic objectives -Others Specific aims are to:
Aim 1. Determine feasibility of tolerance and use of a modified yoga intervention implemented during hospital stay to patients following lumbar spine surgery.
Aim 2. Determine the effectiveness of modified yoga intervention implemented during hospital stay to improve physical function and decrease pain and anxiety post lumbar spine surgery compared to usual care.
Aim 3. Determine the feasibility of an 8 week home-based modified yoga program specific for patients who have had lumbar spinal surgery immediately following hospital discharge
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase

Assessment
Primary outcomes NIH pain assessment and history,
Beck anxiety inventory
Timed up and go test
Key secondary outcomes Demographics,
Medications,
Pittsburgh sleep quality index
Pain catastrophizing scale
Perceived stress scale -10

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Yoga
Interventions/Control_2 Control
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
40 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Inclusion criteria:
Adults between 40 and 80 yrs old scheduled for lumbar spine surgery (laminectomy with or without fusion)
Key exclusion criteria Exclusion criteria

1) cancer related pain, 2) cauda equina syndrome, 3) spinal tumor, 4) regular practice of Yoga
Target sample size 40

Research contact person
Name of lead principal investigator Neena Sharma
Organization The University of Kansas Medical Center
Division name Department of Physical Therapy
Address 3901 Rainbow Blvd/ MS 2002, Kansas City, KS, 66160
TEL 913-588-4566
Email NSHARMA@kumc.edu

Public contact
Name of contact person Kosaku Aoyagi
Organization The University of Kansas Medical Center
Division name Department of Physical Therapy
Address 3901 Rainbow Blvd/ MS 2002, Kansas City, KS, 66160
TEL 913-588-4340
Homepage URL http://www.kumc.edu/school-of-health-professions/research/clinical-orthopedic-rehabilitation-and-res
Email kaoyagi@kumc.edu

Sponsor
Institute N/A
Institute
Department

Funding Source
Organization N/A
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 18 Day

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 07 Month 11 Day
Anticipated trial start date
2016 Year 10 Month 11 Day
Last follow-up date
2017 Year 11 Month 11 Day
Date of closure to data entry
2017 Year 12 Month 31 Day
Date trial data considered complete
2017 Year 12 Month 31 Day
Date analysis concluded
2018 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 05 Month 15 Day
Last modified on
2018 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037167

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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